Administrative Core

行政核心

• 批准号: 10159118
• 负责人: Deborah J Anderson
• 金额: $ 51.52万
• 依托单位: BOSTON UNIVERSITY MEDICAL CAMPUS
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-14 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10159118
• 关键词: Achievement; Adherence; Antibodies; Antigen Targeting; Award; Biological; Biological Products; Blood; Boston; Clinical; Clinical Management; Clinical Research; Communication; Contraceptive Agents; Contraceptive methods; Data; Database Management Systems; Development; Experimental Designs; Film; Fostering; Goals; Grant; Grant Review; Guidelines; HIV-1; Human; Immobilization; Individual; Industrialization; Infertility; Infrastructure; Leadership; Libraries; Liquid substance; Louisiana; Methods; Monitor; Monoclonal Antibodies; North Carolina; Phase I Clinical Trials; Prevention; Primates; Program Reviews; Publications; Reagent; Research; Research Personnel; Research Project Grants; Resource Allocation; Resource Sharing; Schedule; Scientist; Sexually Transmitted Diseases; Simplexvirus; Spermatozoa antibody; Statistical Data Interpretation; Surface; Technology; Testing; Topical application; United States National Institutes of Health; Universities; Vaginal Ring; Vaginal Route of Drug Administration; Virginia; Woman; base; career; clinical database; data acquisition; data management; data sharing; experience; interest; medical schools; meetings; pathogen; pre-clinical research; programs; sperm cell; statistics; success; symposium; web site

ADMINISTRATIVE CORE: ABSTRACT The Contraception Research Center at Boston University School of Medicine (BUSM-CRC) brings together an experienced team of clinical, industrial and basic scientists to develop and test new contraceptive products based on topical administration of Human Contraceptive Antibody (HCA). HCA was originally isolated from the blood of an infertile but otherwise healthy woman. The antibody targets an antigen on the surface of human sperm and can agglutinate/immobilize sperm within seconds. We propose to release HCA monoclonal antibodies from a quick-dissolving film for short-term (on demand) protection, and from an intravaginal ring (IVR) for protection lasting up to one month. Our long term goal is to combine HCA with antibodies against pathogens such as HIV-1 and HSV that cause serious sexually-transmitted infections (STIs), to provide a new multipurpose prevention technology (MPT) platform that delivers both contraception and protection against STIs. Success of the BUSM-CRC will rely upon an Administrative Core that will provide scientific and administrative leadership in coordinating the three developmental and translational Projects that make up the program. The Administrative Core will also coordinate data and materials acquisition and sharing so that the research progresses in an integrated iterative fashion to meet individual project and programmatic milestones, and foster the development of junior scientists interested in pusuing a career in contraception/MPT research. The Specific Aims of the Administrative Core are: 1. To provide scientific leadership and administrative oversight. Specifically, the Administrative Core will establish an Executive Committee (EC) for ongoing assessment of project and core milestones, resource allocation and changes to the experimental design. The Administrative Core will also convene an external Scientific Advisory Panel (SAP) to review the program in years 2 and 4. The Administrative Core will facilitate communication through scheduled conference calls and investigator meetings, provide financial and administrative support, and insure adherence to institutional and federal guidelines 2. To coordinate data and materials acquisition and sharing to insure that project and program milestones are met. The Administrative Core will be responsible for the reagent/research material and data management and sharing plan, and for monitoring milestone achievements. 3. To manage the clinical database and statistical analysis for the two Phase 1 clinical trials. 4. To award pilot grants to encourage junior and other scientists to enter the contraception/MPT field.

管理核心：摘要 波士顿大学医学院避孕研究中心（BUSM-CRC）汇集了一个 由经验丰富的临床、工业和基础科学家组成的团队，开发和测试新的避孕产品 基于人类避孕抗体（HCA）的局部施用。HCA最初是从 一个不孕但健康的女人的血该抗体靶向人体表面的抗原， 精子，并能在几秒钟内凝集/消灭精子。我们建议释放HCA单克隆抗体 从用于短期（按需）保护的快速溶解膜，以及用于 保护期长达一个月。我们的长期目标是将联合收割机HCA与抗病原体的抗体结合起来 如引起严重性传播感染（STI）HIV-1和HSV，提供一种新的多用途 预防技术（MPT）平台，提供避孕和预防性传播感染的保护。 BUSM-CRC的成功将取决于一个行政核心，该核心将提供科学和行政支持。 领导协调构成该计划的三个发展和翻译项目。的 行政核心还将协调数据和材料的获取和共享， 以集成的迭代方式取得进展，以满足单个项目和计划里程碑，并促进 培养有兴趣从事避孕/MPT研究的年轻科学家。 行政核心的具体目标是： 1.提供科学领导和行政监督。具体而言，行政核心将 设立一个执行委员会，不断评估项目和核心里程碑、资源 分配和实验设计的变化。行政核心还将召开一次外部会议， 科学咨询小组（SAP）将在第2年和第4年审查该计划。行政核心将促进 通过预定的电话会议和研究者会议进行沟通，提供财务和 行政支持，并确保遵守机构和联邦指导方针 2.协调数据和资料的获取和共享，以确保项目和计划的顺利进行 里程碑已经实现。管理核心将负责试剂/研究材料和数据 管理和共享计划，并监测里程碑成就。 3.管理两项I期临床试验的临床数据库和统计分析。 4.发放试点赠款，以鼓励初级科学家和其他科学家进入避孕/MPT领域。